NCT04304911

UP in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System

Implementation, Effficacy and Cost-effective Study of the Unified Protocol in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Instituto de Investigación Sanitaria Aragón · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present randomized, controlled trial will compare the efficacy, cost-effectiveness, and implementation characteristics of a blended intervention based on the Unified Protocol (UP) for transdiagnostic treatment of emotional disorders against the treatment as usual in a sample of patients with emotional disorders in the Spanish National Health System.

Detailed description

Emotional disorders (EDs;including anxiety disorders, unipolar mood disorders, and related disorders) are the most prevalent mental disorders in the general population. In Spain, anxiety disorders and mood disorders affect approximately two million (4.1%) and two and half million (5.2%) individuals, respectively. As a result of their prevalence in the society, EDs have become an alarming health problem due to their associate costs. These disorders have a direct cost of 22.000 million euros (500 euros per capita and year). The total expense of these disorders entails 2.2% of the Gross Domestic Product in Spain. Due to the excessive demand for treatment, mental health services of our National Health System (NHS) are collapsed with large waiting lists, which results in a great difficulty to dedicate the recommended time to attend patients who require psychological treatment. Therefore, it is needed to find solutions for the effective and cost-effective treatment of EDs in our NHS. In the last years, several solutions have been proposed to alleviate this important health problem. The general objective of this project is to contribute to the dissemination of evidence-based psychological treatments in our Public National Health System for the most prevalent mental disorders in our society, emotional disorders (EDs). The investigators will study the efficacy, cost-effectiveness, and implementation characteristics (acceptability, usability, and utility) of a blended intervention which will enhance face-to-face treatment by incorporating an app-based intervention onsite treatment. Based on the most recent clinical advances in the treatment of EDs, the investigators will use the Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP). The investigators hypothesize that the blended intervention will be superior to the treatment as usual (face-to-face, specific-disorder treatment) because patients in the UP-APP condition will continue working with the app at home between sessions. In sum, this project is composed of three connected studies: a validation study in a clinical sample of patients with EDs, two pilot studies to help develop the app based on the UP principles, and a multicenter, randomized and controlled clinical trial that will be conducted by 12 clinical psychologist working in 8 different provinces in Spain.

Conditions

• Emotional Disorder
• Anxiety Disorders
• Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Blended intervention (UP-APP)	Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP)
BEHAVIORAL	Cognitive Behavioral Therapy (TAU)	TAU group that carries out Cognitive Behavioral Therapy in an individual format

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2025-06-01
• First posted: 2020-03-12
• Last updated: 2023-09-25

Locations

1 site across 1 country: Spain